Appropriateness of Non-vitamin K Antagonist Oral Anticoagulants Dosing According to Different Prescription Guides Used in Belgian Ambulatory Care
ConclusionsInappropriate NOAC dosing is present in almost twenty percent of AF patients according to the SmPC and requires further education of health care professionals and frequent reassessment of NOAC dosing. However, a significant lower prevalence of underdosing was present when judged by the 2018 EHRA criteria, likely reflecting decision making in complex AF patients. Perceived frailty, weight, renal function and type of NOAC are the main determinants of deviated dosing. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 20, 2022 Category: Drugs & Pharmacology Source Type: research

Clinical Characteristics and Implications of Bradycardia in COVID-19 Patients Treated with Remdesivir: A Single-Center Retrospective Cohort Study
ConclusionsBradycardia that occurs during or shortly after remdesivir treatment in COVID-19 patients may be associated with an increased rate of in-hospital mortality. However, COVID-19 and its cardiac complications cannot be excluded as potential contributors of bradycardia in the present study. Future studies are needed to further delineate the cardiac characteristics of COVID-19 and remdesivir. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 17, 2022 Category: Drugs & Pharmacology Source Type: research

Safety, Tolerability, and Pharmacokinetics of Ropanicant (SUVN-911), a Novel Alpha4 Beta2 Nicotinic Acetylcholine Receptor ( α4β2 nAChR) Antagonist, in Healthy Adult and Elderly Subjects
ConclusionsRopanicant was found to be safe and well tolerated following single and multiple oral administrations in healthy subjects. Ropanicant showed nonlinear pharmacokinetics and accumulation following multiple dosing. Urinary excretion represents an insignificant elimination pathway for ropanicant. Ropanicant pharmacokinetics were sex dependent, and food and age had no effect on its  pharmacokinetics.Clinical Trial RegistrationNCT03155503 and NCT03551288. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 13, 2022 Category: Drugs & Pharmacology Source Type: research

Midostaurin as the Most Likely Cause of Bilateral Adrenal Masses in a Patient with Acute Myeloid Leukemia
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 10, 2022 Category: Drugs & Pharmacology Source Type: research

Cost –Utility Analysis of Pharmacogenetic Testing Based on CYP2C19 or CYP2D6 in Major Depressive Disorder: Assessing the Drivers of Different Cost-Effectiveness Levels from an Italian Societal Perspective
ConclusionsOur findings suggest that screenings for both CYP2C19 and CYP2D6 enzymes for patients with MDD are cost-effective for a WTP threshold of 75,000 € per QALY, and provide relevant suggestions about the most important aspects to be further explored in clinical studies aimed at addressing the cost-effectiveness of genetic testing for patients diagnosed with MDD. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - August 5, 2022 Category: Drugs & Pharmacology Source Type: research

Leflunomide Exposure and Teriflunomide Concentrations up to the Third Trimester of Pregnancy: A Case Report
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 27, 2022 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics of Imeglimin in Caucasian and Japanese Healthy Subjects
ConclusionImeglimin was safe and well tolerated in these two phases 1 studies, with pharmacokinetics comparable between the two populations.Clinical Trial RegistrationsEudraCT 2005-001946-18 and 2014-004679-21. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 22, 2022 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of a Fixed-Dose Combination of Cinnarizine 20 mg and Dimenhydrinate 40 mg in the Treatment of Patients with Vestibular Vertigo: An Individual Patient Data Meta-Analysis of Randomised, Double-Blind, Controlled Clinical Trials
ConclusionThe findings of the present meta-analysis indicate that the fixed combination of cinnarizine and dimenhydrinate is a safe and potentially superior treatment option for patients suffering from central and/or peripheral vestibular vertigo, as compared to current standard treatments such as cinnarizine, dimenhydrinate or betahistine given alone in monotherapy. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 21, 2022 Category: Drugs & Pharmacology Source Type: research

Clinical Response to Futibatinib in Patients with High-Level FGFR2-Amplified Advanced Gastric Cancer: Two Case Reports
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 19, 2022 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetic Drug –Drug Interaction Studies Between Trilaciclib and Midazolam, Metformin, Rifampin, Itraconazole, and Topotecan in Healthy Volunteers and Patients with Extensive-Stage Small-Cell Lung Cancer
ConclusionsOverall, the drug –drug interaction and safety profiles of trilaciclib in these studies support its continued use in patients with extensive-stage small-cell lung cancer.Clinical Trial RegistrationStudy 106: EudraCT number: 2019-002303-18; Study 114: not applicable; Study 03: Clinicaltrials.org: NCT02514447; August 2015. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 16, 2022 Category: Drugs & Pharmacology Source Type: research

Modeling the Potential Impact of Remdesivir Treatment for Hospitalized Patients with COVID-19 in Saudi Arabia on Healthcare Resource Use and Direct Hospital Costs: A Hypothetical Study
ConclusionsThe treatment with remdesivir may improve patient outcomes and reduce the burden on healthcare resources during this pandemic. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 15, 2022 Category: Drugs & Pharmacology Source Type: research

Nonmetastatic Castration-Resistant Prostate Cancer: Current Challenges and Trends
AbstractProstate carcinoma is a highly prevalent biologically and clinically diverse disease, generally associated with a consistent elevation of prostate-specific antigen levels. Castration-resistant prostate cancer represents a heterogeneous clinical setting that ranges from patients with an asymptomatic prostate-specific antigen elevation after hormone blockade failure and good performance status to patients with significant debilitating symptoms and rapidly progressive disease, leading to death. Nonmetastatic castration-resistant prostate cancer is a transient disease stage defined over specific criteria established wi...
Source: Clinical Drug Investigation - July 13, 2022 Category: Drugs & Pharmacology Source Type: research

Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet
ConclusionsThe smaller-sized tablets (10 and 50 mg) and the newly developed oral powder formulations of venetoclax can be used interchangeably with the 100 mg tablets to improve the patients ’ experience, while maintaining adequate exposure.Clinical Trials  IdentifiersNCT01682616, 11 September 2012; NCT02005471, 9 December 2013; NCT02242942, 17 September 2014; NCT02203773, 30 July 2014; NCT02287233, 10 November 2014; NCT02993523, 15 December 2016; NCT03069352, 3 March 2017. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 13, 2022 Category: Drugs & Pharmacology Source Type: research

Cost-Effectiveness of Icosapent Ethyl, Evolocumab, Alirocumab, Ezetimibe, or Fenofibrate in Combination with Statins Compared to Statin Monotherapy
ConclusionsIcosapent ethyl is cost effective for primary and secondary cardiovascular prevention at an annual price of £2064 in the UK. For PCSK9 inhibitors, price discounts or prescription restrictions are necessary to achieve cost effectiveness.Graphical abstract (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 11, 2022 Category: Drugs & Pharmacology Source Type: research

Paxlovid-Tacrolimus Drug –Drug Interaction in a 23-Year-Old Female Kidney Transplant Patient with COVID-19
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - July 11, 2022 Category: Drugs & Pharmacology Source Type: research